73647-004-03

73647-004-03
SPL v5
SPL
SPL Set ID f6538e3e-4663-679c-e053-2995a90a87b5
Route
TOPICAL
Published
Effective Date 2024-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Sorbic Acid Methyl Salicylate Cannabidiol Water Glycerin Salicylic Acid Carbomer 940 Sodium Hydroxide Ceteareth-25 Benzyl Alcohol Alcohol Calendula Officinalis Flower Fd&c Blue No. 1 Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-03-14 Until 2027-04-24

Description

Menthol ………………………………...…………………………….…. 4%


Medication Information

Warnings and Precautions

• For external use only.

• Ask a doctor before use if you have redness over affected area.

Description

Menthol ………………………………...…………………………….…. 4%

Uses:

Aid for temporary local relief of minor pain in muscles and joints.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7



• Avoid contact with the eyes or mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not apply to the irritated skin or if excessive irritation develops.

• Do not bandage tightly.

• Do not use with heating pad or device.

• Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Section 51727-6

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Cannabidiol, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Methyl Salicylate, FD&C Blue No. 1 (CI 42090).

Section 53414-9

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol ………………………………...…………………………….…. 4%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Cannabidiol (CBD*) use, while taking any medication, or have any medical condition may be harmful. Consult

a healthcare professional before use.

This product is intended only for use by healthy adults aged 21 years & older.

Directions

Adults over 21 years

Apply a small amount on the affected area.

Massage in circular motion until absorbed, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Just Cbd Roll On Cooling Gel +350

Just Cbd Roll On Cooling Gel +1500


Structured Label Content

Uses: (USES:)

Aid for temporary local relief of minor pain in muscles and joints.

Warnings and Precautions (34071-1)

• For external use only.

• Ask a doctor before use if you have redness over affected area.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)



• Avoid contact with the eyes or mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not apply to the irritated skin or if excessive irritation develops.

• Do not bandage tightly.

• Do not use with heating pad or device.

• Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Cannabidiol, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Methyl Salicylate, FD&C Blue No. 1 (CI 42090).

Section 53414-9 (53414-9)

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol ………………………………...…………………………….…. 4%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Cannabidiol (CBD*) use, while taking any medication, or have any medical condition may be harmful. Consult

a healthcare professional before use.

This product is intended only for use by healthy adults aged 21 years & older.

Directions (DIRECTIONS)

Adults over 21 years

Apply a small amount on the affected area.

Massage in circular motion until absorbed, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Just Cbd Roll On Cooling Gel +350 (JUST CBD ROLL-ON COOLING GEL +350)

Just Cbd Roll On Cooling Gel +1500 (JUST CBD ROLL-ON COOLING GEL +1500)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)